Influenza Immunity in Children

NCT02559505 | Completed Results

• 1 other identifier: RSRB00058437
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates how different methods of early exposure to influenza (natural infection, live attenuated influenza vaccination, inactivated influenza vaccination) initially stimulate immunity and poise the immune system to respond to a future challenge with the inactivated influenza vaccine.

Conditions

Influenza

Keywords

natural influenza infection; live attenuated influenza vaccination (LAIV); inactivated influenza vaccination (IIV); infants; children

Outcome Measures

Primary Outcomes (5)

• Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects

  % H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining

  Visit 2 (day 8-14 post enrollment)

• Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects

  % H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining

  Visit 3 (day 20-28 post enrollment)

• Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects

  % H3- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining

  Visit 4 (day of vaccination year 2)

• Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects

  % H3 protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining

  Visit 5 (day 8-14 post-vaccination year 2)

• Mean Percent of IFNg+ CD69+ CD4 T Cells Between Acute (H3N2) Infected and Vaccinated Subjects

  % H3 Protein- and nucleoprotein (NP)-specific CD4 T cells were measured using intracellular cytokine staining

  Visit 6 (day 20-28 post-vaccination year 2)

Secondary Outcomes (2)

• Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets

  Baseline to day 24 study year 1

• Mean Change in Percent of IFNg+ CD69+ CD4 T Cells Between Vaccinated Subjects in Different Age Subsets

  Baseline to day 24 study year 2

Other Outcomes (1)

• Change From Baseline to Day 10 and Day 24 in PBMC Gene Expression

  Days 10 and 24 post vaccination

Study Arms (8)

6-12 months Seasonal IIV

EXPERIMENTAL

Children 6 - 12 months of age vaccinated with seasonal IIV

Biological: Seasonal IIV 0.25 mL dose

3-12 months natural infection

EXPERIMENTAL

Children 3-12 months of age presenting with natural influenza infection

Other: Natural influenza infection; Biological: Seasonal IIV 0.5 mL dose

13-35 months Seasonal IIV

EXPERIMENTAL

Children 13-35 months of age vaccinated with seasonal IIV

Biological: Seasonal IIV 0.25 mL dose

13-35 months natural infection

EXPERIMENTAL

Children 13-35 months of age presenting with natural influenza infection

Other: Natural influenza infection; Biological: Seasonal IIV 0.5 mL dose

3-5 years Seasonal IIV

EXPERIMENTAL

Children 3-5 years of age vaccinated with seasonal IIV

Biological: Seasonal IIV 0.5 mL dose

3-5 years natural infection

EXPERIMENTAL

Children 3-5 years of age presenting with natural influenza infection

Other: Natural influenza infection; Biological: Seasonal IIV 0.5 mL dose

6-8 years Seasonal IIV

EXPERIMENTAL

Children 6-8 years of age vaccinated with seasonal IIV

Biological: Seasonal IIV 0.5 mL dose

6-8 years natural infection

EXPERIMENTAL

Children 6-8 years of age presenting with natural influenza infection

Other: Natural influenza infection; Biological: Seasonal IIV 0.5 mL dose

Interventions

Seasonal IIV 0.25 mL dose BIOLOGICAL

Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age

Also known as: Inactivated influenza vaccine

13-35 months Seasonal IIV; 6-12 months Seasonal IIV

Natural influenza infection OTHER

Children enrolled on presentation to their primary care provider with a natural influenza infection

13-35 months natural infection; 3-12 months natural infection; 3-5 years natural infection; 6-8 years natural infection

Seasonal IIV 0.5 mL dose BIOLOGICAL

Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age

Also known as: inactivated influenza vaccine

13-35 months natural infection; 3-12 months natural infection; 3-5 years Seasonal IIV; 3-5 years natural infection; 6-8 years Seasonal IIV; 6-8 years natural infection

Eligibility Criteria

• Age: 3 Months - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age
• Between 6 and 12 months to participate in the vaccination arm of cohort 1 (cohort 1A)
• Between 3 and 12 months to participate in the natural infection arm of cohort 1 (cohort 1B)
• Between 13 and 35 months of age to participate in either the vaccination or natural infection arm of cohort 2
• Between 36 months and 5 years of age to participate in either the vaccination or natural infection arm of cohort 3
• Between 6 years and 8 years of age to participate in either the vaccination or natural infection arm of cohort 4
• Gestational age of ≥37 weeks at birth
• Parent/guardian can provide informed consent
• Available for the duration of the study
• History of previous IIV administration ONLY for participation in the vaccination arm of cohorts 2, 3, or 4
• Acute illness documented to be due to influenza virus ONLY for participation in the natural infection arms of cohorts 1-4

You may not qualify if:

• Immunosuppression as a result of an underlying illness or condition (including HIV or a primary immunodeficiency syndrome)
• Active neoplastic disease
• Use of potentially immunosuppressive medications currently or within the past year (including chemotherapeutic agents) or chronic (\>2 weeks) use of oral or inhaled steroid therapy
• A diagnosis of asthma requiring chronic controller medication
• Previous administration of influenza vaccine in the current influenza season ONLY for subjects receiving an influenza vaccination
• Receipt of immunoglobulin or another blood product within the year prior to study enrollment
• An acute illness within the previous 3 days or temperature \>38o on screening EXCEPT for participation in the natural infection arms of cohorts 1-4
• A contraindication to influenza vaccination EXCEPT infants between 3 and 5 months presenting with natural influenza infection whose only contraindication is their current age

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Shannon I, White CL, Yang H, Nayak JL. Differences in Influenza-Specific CD4 T-Cell Mediated Immunity Following Acute Infection Versus Inactivated Vaccination in Children. J Infect Dis. 2021 Jun 15;223(12):2164-2173. doi: 10.1093/infdis/jiaa664.

  PMID: 33074330 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Jennifer Nayak
• Organization: University Of Rochester

Jennifer_Nayak@URMC.Rochester.edu

5852767404

Study Officials

• Jennifer L Nayak, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: September 24, 2015
• Study Start: October 1, 2015
• Primary Completion: July 3, 2020
• Study Completion: July 3, 2020
• Last Updated: September 2, 2021
• Results First Posted: September 2, 2021

Record last verified: 2021-08

Locations

US (1)